FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K Number: K013568
·
Decision Dec 21, 2001
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
96
Review Days
56
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Basic Information
- Device Name
- CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K Number
- K013568
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- October 26, 2001
- Decision Date
- December 21, 2001
- Product Code
- DHX
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
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|---|---|---|---|
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| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | Nov 20, 2002 | Substantially Equivalent |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Jul 24, 2002 | Substantially Equivalent |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | Jul 5, 2002 | Substantially Equivalent |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Mar 27, 2002 | Substantially Equivalent |
| K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM | Dec 6, 2001 | Substantially Equivalent |